Senior Viral Vector Analytics Lead, CMC

Immix Biopharma, Inc.; Los Angeles (CA); On-site; USD 180,000 - 230,000; Full time

Job summary

The Senior CMC Consultant for Viral Vector Analytics at Immix Biopharma provides oversight of analytical strategy across clinical to commercial stages, focusing on retroviral vector analytics and lifecycle management from development to validation at CDMOs and CTLs.

The role liaises with manufacturing, process development, QA/QC, and program teams to deliver timely results, manage risk, and ensure compliant, efficient vector quality for patients and program milestones.

Qualifications

• Advanced degree (MS or PhD) in life sciences with 8+ years of applicable work experience in cell and gene therapy.
• Strong technical knowledge of retroviral vector analytics lifecycle (safety, potency, purity, identity, strength).
• Demonstrated hands-on problem-solving, assay troubleshooting, and investigations.

Responsibilities

• Provides oversight and leadership for the vector analytics program from clinical to commercial stages, aligning with objectives and timelines.
• Leads analytical method development and validation for retroviral vector programs (cell-based/molecular/microbial assays).
• Executes risk-based strategies for vector analytics integrated with manufacturing and product lifecycle.
• Leads planning and delivery of the vector stability program.
• Ensures timely issue resolution and strong collaboration with CDMOs/CTLs and cross-functional teams.
• Reviews analytical method qualification/validation documents and regulatory submissions support.
• Contributes to regulatory document sections as required.

Skills

Vector analytics lifecycle

Assay troubleshooting

Cross-functional communication

Problem solving

Data analytics

Education

MS or PhD in life sciences

Job description

The Senior CMC Consultant for Viral Vector Analytics at Immix Biopharma provides oversight of analytical strategy across clinical to commercial stages, focusing on retroviral vector analytics and lifecycle management from development to validation at CDMOs and CTLs.

The role liaises with manufacturing, process development, QA/QC, and program teams to deliver timely results, manage risk, and ensure compliant, efficient vector quality for patients and program milestones.